Cleared Traditional

SPIFE LD-12 KIT, MODEL 3338

K022455 · Helena Laboratories · Chemistry
Oct 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K022455 is an FDA 510(k) clearance for the SPIFE LD-12 KIT, MODEL 3338, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 1, 2002, 67 days after receiving the submission on July 26, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K022455 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2002
Decision Date October 01, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1445

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